Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCL in Subjects With Advanced Solid Tumors

Exclusion Criteria

• •1. Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment \< 4 weeks prior to the Screening Visit.
• •2. Prior treatment with ≥ 150 mg/m2 doxorubicin HCl or Doxil® cumulative dose, or epirubicin ≥ 150 mg/m2.
• •3. Exposure to any investigational agent within 30 days of Randomization.
• •4. Evidence of active or uncontrolled central nervous system (CNS) metastasis (negative imaging study performed due to suspicion of CNS metastasis within 4 weeks of Screening Visit).
• •5. History of other malignancies except cured basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.
• •6. Laboratory values: Screening serum creatinine ≥ 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the ULN if no liver metastases or 5 times the ULN if liver metastases, total bilirubin \> 2 times the ULN, white blood cell (WBC) count \< 3500/mm3, or absolute neutrophil count (ANC) \< 1500/mm3, platelet concentration \< 100,000/mm3, hematocrit level \< 25% for females or \< 27% for males, or coagulation tests (prothrombin time \[PT\]; partial thromboplastin time \[PTT\]), International Normalized Ration (INR) \> 1.5 times the ULN, serum albumin \< 2.0g/dL.
• •7. Clinically evident congestive heart failure (CHF) \> class II of the New York Heart Association (NYHA) guidelines.
• •8. Baseline QTc \> 470 msec and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QTc prolongation is not allowed.
• •9. Serious clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
• •10. History or signs of active coronary artery disease with or without angina pectoris.